Vera's TRUTAKNA Wins FDA Nod: The eGFR Readout That Decides the IgAN Race

The FDA just quietly stopped publishing its drug rejection letters — reversing the signature transparency push of the Makary era, and almost nobody noticed.

Meanwhile AstraZeneca and GSK both cut respiratory deals with the same Chinese partner in a single day, Vera's kidney drug beat Vertex to market, and Bristol's Krazati just failed a confirmatory trial. Busy Wednesday. Let's get into it.

Welcome to The Pharma Closeout for Wednesday, July 8th. I'm Alex Mercer.

And I'm Maya Patel.

Here's what's actually happening. The FDA has paused its policy of releasing complete response letters — the rejection letters that spell out exactly why a drug got turned down. Fierce Biotech confirmed it today. This was the centerpiece of the "radical transparency" agenda under Marty Makary and RFK Jr.

And it wasn't a token gesture. Last September the agency committed to posting these in real time — that came with a batch of 89, on top of an earlier drop of around 200. Some were high-profile: Ultragenyx's Sanfilippo gene therapy, Capricor's Duchenne cell therapy, Replimune's melanoma drug.

Then in April a pharma company — unnamed — filed a citizen petition through Covington and Burling, arguing the letters were leaking proprietary information. The agency temporarily paused. And here's the tell: Sobi got rejected on its gout drug June 26th. That letter never got published.

OK, but I'd push back on calling this a reversal. Read the petition. It cited actual unredacted material — confidential information that surfaced in the published letters for Lykos, for Stealth BioTherapeutics. Capricor said it wasn't even notified before its letter went public, and that the FDA misread its efficacy data. That's not the principle failing. That's the redaction process being broken.

That's a fair distinction — the mechanics were sloppy. But here's why the effect is still a reversal: while the agency fixes the plumbing, the window is closed. And in parallel they've proposed a rule that would expand the commissioner's discretion to release these letters and — this is the part I'd underline — eliminate the presumption that the mere existence of a marketing application is confidential.

Right — and that proposed rule cuts the opposite way from the pause. So the honest read isn't "transparency won" or "transparency lost." It's that the agency retreated tactically to rebuild the legal foundation. If that rule lands, they come back with more authority than they had in September. For now, though, there's a real information gap.

And that gap has teeth. The competitive read: if you run competitive intelligence, that database was a live feed of exactly why your rivals' programs died — manufacturing, trial design, safety signals. Everything issued after April went dark. You're back to reading between the lines of a one-paragraph press release.

And the asymmetry favors whoever's getting rejected. A rejection you don't have to disclose becomes a bad quarter you get to characterize on your own terms. So watch the language over the next two quarters. The vaguer a company gets about a setback, the more you can assume the letter said something they'd rather you not read.

Which is a nice segue, because the disclosure story wasn't the only thing moving today. Sino Biopharmaceutical had one of the busiest days of any company this year — separate respiratory pacts with both AstraZeneca and GSK, announced the same Wednesday. The AstraZeneca piece is the bigger one: its subsidiary Chia Tai Tianqing licensed TQC3721, a COPD candidate, to AstraZeneca for everything outside China — $200 million upfront, up to $1.9 billion in milestones.

The GSK side is a commercial deal, not a pipeline bet. Chia Tai Tianqing picks up mainland China rights to Trelegy Ellipta and Anoro Ellipta. Per Benzinga, Trelegy's China label expanded this year to add asthma — making it, they say, the only single-inhaler triple therapy approved there for both COPD and asthma. So AstraZeneca's buying a molecule; GSK's monetizing a franchise it already owns through a local distributor.

And this is the second big UK-pharma-into-China tie-up in short order — happening under real US scrutiny of exactly these transactions. Let's bring in Marcus Webb on this one.

Sharp. And the metabolic side of that same story landed overnight — Kailera posted positive topline from two Hengrui Phase 3 obesity trials in China. Mean weight loss up to 10.9% at week 44, 11.1% at week 50, for its oral GLP-1, HRS-7535.

That's the number that travels. An oral GLP-1 clearing eleven percent is a direct shot at Lilly's orforglipron — and the oral-versus-oral fight is where the next margin war gets decided, not injectable-versus-injectable.

Couple of quick hits before we move on. Oruka Therapeutics fell after hours when Fairmount unloaded a $300 million stake — 3.55 million shares, disclosed via SEC filing. Novartis cut another 322 staffers based out of its US headquarters. Evonik's putting $100 million into upgrading its Indiana drug-substance plant. And Prime Medicine won its gene-editing dispute with Beam over an AATD candidate.

The Prime-Beam result is the one I'd file away. When two editing platforms are litigating over the same target, that's a signal the underlying IP is worth fighting for — which usually precedes a licensing or partnership conversation, not follows it.

The thread through all of it: the center of gravity in early-stage licensing has moved east, and the deal terms say the buyers already know it.

On the regulatory front, the headline approval belongs to Vera Therapeutics. The FDA cleared atacicept — branded Trutakna — for IgA nephropathy. Per BioWorld, it's the first dual-target inhibitor approved in the indication, and it buys Vera close to a five-month head start on Vertex.

We flagged Vera yesterday — the piece to add is the competitive clock. Otsuka's already in this space, so Vera isn't landing in open water. It's landing in a market that's forming fast.

And the data point that actually decides the fight is still ahead — Vera's eGFR readout from the ORIGIN 3 trial in Q3. Approval gets you the label. Kidney-function data is what gets a nephrologist to switch a patient. That's the readout I'm circling.

Meanwhile, the flip side of the accelerated-approval bargain came due today.

It did — Bristol Myers detailed that Krazati failed its confirmatory trial in colorectal cancer. That's the deal you make for early access finally getting called, and this one didn't clear. It's a reminder that a surrogate endpoint is a loan, not a gift.

And on the legal side — Tampa General sued Lilly over its 340B restrictions. The hospital says Lilly's cutoff forced Mounjaro's price sharply higher. It's a Florida deceptive-trade-practices claim, and it's the opening shot in a broader fight over whether drugmakers can condition discounts on data requirements.

Put today's regulatory beat together and the through-line is disclosure and access — the CRL pause, the 340B suit, even a drugmaker caught faking a doctors' petition to dodge a China price cut. Every one of these is about who controls information and who controls price. If you're modeling regulatory risk for the back half of the year, that's the axis moving — not approvals, but the rules around what gets shown and what gets charged.

Looking ahead. Biohaven is teeing up a fight with Lilly in muscle-sparing obesity — its Phase 2 readout for taldefgrobep alfa is due in the second half of this year. Lilly, Regeneron and Scholar Rock are all chasing the same anti-myostatin thesis, and Lilly's own bimagrumab data is expected sometime this year after it halted one study.

The muscle-sparing angle is real but unproven — preserve lean mass while you strip fat. Nobody's shown durable data on it yet. Biohaven's readout is one of the first honest tests of whether that's a differentiator or a slide in a pitch deck.

Two more on the board, and they tighten fast. On Amgen, the Duke re-adjudication of the Tavneos ADVOCATE data is due to the FDA imminently — we said that was the one to watch, and it hasn't landed yet, still on track for the coming weeks. And Pfizer got cut to Hold by HSBC on Monday, on delayed pipeline catalysts and leadership questions — which lines up with what we flagged last week: the next Seagen ADC readout either rebuilds the thesis or it doesn't.

So late July becomes two very different stress tests. Amgen is about whether a re-analyzed dataset holds up under a second look. Pfizer is about whether a $43 billion oncology bet starts paying off. One's a credibility question, one's a returns question — and they land within days of each other.

And that is your Pharma Closeout for Wednesday, July 8th — the FDA quietly closing the CRL window, Sino Biopharm doubling up with AstraZeneca and GSK, Vera's IgAN approval, and a Krazati confirmatory miss. This industry does not slow down, and honestly, we love it. If you want to stay across this space, subscribe wherever you listen — we're back tomorrow.

We are. And keep an ear on that CRL pause — the vaguer the setback language gets, the more it's telling you. See you tomorrow!